Ignite Creation Date:
2024-05-06 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06217016
Status:
SUSPENDED
Last Update Posted:
2024-04-23
First Post:
2024-01-05
Brief Title:
Effect of ICCAUT Strategy on Postoperative Urinary Retention After Radical Rectal Cancer Surgery ICCAUT-2
Sponsor:
The First Hospital of Jilin University
Organization:
The First Hospital of Jilin University
Study Overview
Official Title:
Effect of Intermittent Urethral Catheter Clamping Combined With Active Urination Training ICCAUT Strategy on Postoperative Re-catheterization Secondary to Urinary Retention After Radical Rectal Cancer Surgery ICCAUT-2
Status:
SUSPENDED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The enrollment of ICCAUT-2 may conflict with the enrollment of ICCAUT-1 so we suspended the enrollment of ICCAUT-2 It will be started after we finish the enrollment of ICCAUT-1
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this trial is to investigate the effect of bladder training on the incidence of re-catheterization after proctectomy In this study the bladder training include intermittent urethral catheter clamping combined with active urination training which we called ICCAUT strategy This prospective single-center randomized controlled trial will enroll patients with rectal cancer who will be randomized in a 11 ratio to the ICCAUT group or the free-drainage group In the ICCAUT group patients will undergo intermittent clamping of the urinary catheter before its removal Each time the catheter is released we will encourage the patients to actively initiate urination to facilitate complete bladder emptying While patients in the free-drainage group will not undergo any specific training The urinary catheter will be removed on the second postoperative day for both groups The primary endpoint is the incidence of re-catheterization due to urinary retention Secondary endpoints include urinary tract infection UTI time of first urination after catheter removal residual urine volume after the first urination postoperative morbidity and mortality within 30 days as well as urinary function within 30 postoperative days
Detailed Description:
Urinary catheter placement is a standard procedure before proctectomy However the necessity of bladder training prior to catheter removal remains uncertain The objective of this trial is to investigate the effect of bladder training on the incidence of re-catheterization after proctectomy In this study the bladder training include intermittent urethral catheter clamping combined with active urination training which we called ICCAUT strategy This prospective single-center randomized controlled trial will enroll patients with rectal cancer who will be randomized in a 11 ratio to the ICCAUT group or the free-drainage group In the ICCAUT group patients will undergo intermittent clamping of the urinary catheter before its removal Each time the catheter is released we will encourage the patients to actively initiate urination to facilitate complete bladder emptying While patients in the free-drainage group will not undergo any specific training The urinary catheter will be removed on the second postoperative day for both groups The primary endpoint is the incidence of re-catheterization due to urinary retention Secondary endpoints include urinary tract infection UTI time of first urination after catheter removal residual urine volume after the first urination postoperative morbidity and mortality within 30 days as well as urinary function within 30 postoperative days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None